Wound shield for exudate management

ABSTRACT

A wound shield for exudate management may include a conformable frame to circumscribe a wound. The conformable frame may be formed of material for absorbing wound exudate. Exudate absorbing material may also be one of two or more layers of material forming the conformable frame. The layers may be arranged to keep the exudate absorbing layer at some selected distance from a patients skin. Any suitable dressing may be secured over the conformable frame providing separation between the wound and the dressing. The wound frame may provide pressure relief around a wound or pressure sore to permit healing. The conformable frame may be wrapped, in a spiral, around a wound providing an increasing pressure relief by increasing distance from the wound. A conformable frame may be composed of one or more layers of any suitable material and may include adhesive on one or more surfaces to secure the frame to the wound site and or to secure the dressing to the conformable frame. One layer of the two or more layers of material forming the conformable frame may be a wicking or conduit material that draws exudate from the wound and transports the exudate to any suitable media for exudate storage. The exudate storage may be one or more layers of a dressing covering the wound site, or it may be a removable reservoir.

RELATED APPLICATIONS

This application claim priority from copending U.S. Provisional PatentApplication 60/758,389 filed Jan. 12, 2006 and copending U.S. Utilitypatent application Ser. No. 11/303,463 filed Dec. 15, 2005.

FIELD OF THE INVENTIONS

The inventions described below relate to the field of wound caremanagement.

BACKGROUND OF THE INVENTIONS

Wounds occur when the integrity of any tissue is compromised, affectingone or more layers of skin or underlying tissue. Wounds may be caused byan act, surgical procedure, an infectious disease or an underlyingcondition. Examples of open wounds include punctures, abrasions, cuts,lacerations and burns. Chronic wounds are also common ailments andinclude pressure ulcers, diabetic ulcers, arterial ulcers, venous ulcersor combination of all the above. Despite much progress made in the woundcare industry, an efficient and effective method and apparatus forprotecting the wound from injurious contacts is not readily available.

Injurious contacts with foreign objects may be caused from varioussources, ranging from clothing or bed sheets brushing or adhering towound surfaces to adherence of wound dressing to the wound. The latterissue, referred to here as the sticking issue, leads to deleteriousconsequences for the patient. This problem is particularly exacerbatedwhen wounds are left unattended for a substantial period. It is reportedthat in certain circumstances patients are administered morphine towithstand the pain caused from dressing removal, especially with woundshaving a large surface area. Equally important, tearing of skin graft,newly formed cells or scab adhered to dressing disrupts the healingprocess.

Wounds are generally covered to prevent contamination and resultinginfection. Wounds may also be covered for other reasons, includingretaining moisture and absorption of exudate. Wound covering hastraditionally consisted of application of dressings that are in directcontact with the wound. When directly applied on the wound, dressingsadhere and mechanically anchor to wound surface, which may includediffused wound fluid, skin graft, new epidermal cells forming over thewound or the scabby covering of the wound.

The sticking issue has traditionally been addressed by soaking the woundand the dressing adhering to it in water for sometime to soften the scaband make removal easier. Another method is the application of antibioticointments, such as polymyxin B sulfate or bacitracin, to keep thebandage from sticking to the wound. These methods, however, have notsufficiently addressed the sticking issue. As can be appreciated byhealth care professionals, soaking in water or application of ointmentsare not always practicable or recommended.

To better address the sticking issue the medical industry has developed“non-stick” dressings such as Telfa® and Xeroform® and other dressingssuch as hydrocolloids, alginates, hydrofilms, etc. Non-stick, however,is a relative term. Non-stick dressings merely stick less than theirtraditional counterparts, e.g., cotton gauze. Another problem with thesedressings is that their cost is prohibitive for use on wounds requiringconstant change of dressing.

“Non-contact” dressings have also been provided to address the stickingissue. These dressings are primarily designed in the shape of aninverted cup or a raised bandage. The general idea is that the spacewithin the cup or raised bandage covers the wound, but does not come incontact with it.

Similar to the traditional and “non-stick” dressings described above,“non-contact” dressings also fail to efficiently and effectively protectthe wound from contact, including addressing the sticking issue. First,they cannot be sufficiently deformed for the specific contours ofdifferent wounds, such as a narrow, long laceration. Second, they aredesigned in specific sizes that are not necessarily the desirable sizefor the wound.

Aside from their size limitation and lack of deformability, the priorart “non-contact” dressings have other drawbacks. Their complicateddesign makes their costs a prohibitive factor and application difficult.Moreover, whether several dressing sizes bundled together, or more thanone dressing is in use, the prior art non-contact dressings are unableto address wounds on body segments with small surface areas. Forexample, using a large square, oval or circular bandage to cover alarge, narrow and oddly shaped laceration on the forearm or shin isimpractical. The same is true for the face and neck regions. Similarly,due to their specific shape and size, the non-contact dressings of priorart are not able to address wounds located in joints, such as elbows orknees.

What is needed is a method and apparatus for dressing wounds or othersuitable injuries that is conformable, adjustable and flexible toprevent contact with the surface of the wound, permit management ofexudate from the wound, improve the environment immediately adjacent thewound and provide pressure relief for the wound.

SUMMARY

A wound shield for exudate management may include a conformable frame tocircumscribe a wound. Any suitable dressing may be secured over theconformable frame providing separation between the wound and thedressing. The wound frame may provide pressure relief around a wound orpressure sore to permit healing. A conformable frame may be composed ofone or more layers of any suitable material and may include adhesive onone or more surfaces to secure the frame to the wound site and or tosecure the dressing to the conformable frame.

Exudate as used in this application may also include any solid or liquidproduced by the patients body, or applied to or into a patients bodythat sloughs, falls, flows, or is discharged from a wound, the woundsite or the tissue surrounding the wound.

In another aspect of the present disclosure, a conformable frame may beformed of material for absorbing wound exudate. Exudate absorbingmaterial may also be one of two or more layers of material forming theconformable frame. The layers may be arranged to keep the exudateabsorbing layer at some selected distance from a patients skin.

A wound shield for dynamic exudate management may include two or morelayers of material. One layer of the two or more layers of material maybe a wicking or conduit material that draws exudate from the wound andtransports the exudate to any suitable media for exudate storage. Theexudate storage may be one or more layers of a dressing covering thewound site, or it may be a removable reservoir.

A wound shield for exudate management may also include an exteriormembrane to permit exudate transfer out of the wound space. A woundshield including an exterior membrane may also include an exudatecollection apparatus surrounding the wound shield for collecting andremoving exudate from the wound shield and from the patient.

A wound shield for exudate management may also include one or morereclosable or self-closing apertures in the conformable frame to enableexudate management. The exudate aperture may be formed in theconformable frame or in a connector for securing the ends of aconformable frame. The exudate aperture may be engaged as often asnecessary for suitable wound care.

A wound shield may include a conformable frame to circumscribe a wound.Any suitable dressing may be secured over the conformable frame, theconformable frame providing separation between the wound and thedressing. The wound frame may provide pressure relief around a wound orpressure sore to permit healing, allow compression for venous ulcers,retain moisture within the wound environment, absorb exudate, relievepain and trauma associated with dressing removal, allow debridement andapplication of topical medications and or other compounds or chemicals,accelerate healing and facilitate monitoring of wounds. A conformableframe may be composed of one or more layers of any suitable material andmay include adhesive on one or more surfaces to secure the frame to thewound site, to secure the frame to itself and or any suitable closureelement and or to secure the dressing to the conformable frame. A woundshield may be used for humans or any suitable animal.

A wound shield according to the present disclosure may be wrapped one ormore times around a wound site in a spiral to seal the wound site andprovide improved pressure relief. This method of application requiresnot cutting or measuring and may result in one or more circumferentialwraps of the wound. By wrapping multiple times around a wound theconformable frame is contacting more area of the patients skin inincreasing distance from the wound site providing improved pressurerelief. The multiple wraps of the conformable frame may also includeexudate absorbent material increasing the capacity of the conformableelement and or cover bandage to absorb and store exudate.

A wound shield according to the present disclosure may be a simple,versatile, inexpensive and readily applicable apparatus and method forwound protection. It may include a conformable wound-protecting framethat may conform to the specific contour and size of any wound and maybe used with any suitable dressing. A wound shield prevents foreignobjects such as clothing, dressings and other such items from contactingthe wound. Cotton gauze or other suitable dressing may be placed on orengage a wound protecting frame to completely protect the wound fromharmful contact with any object. Alternatively, special covers, seals,and or lids may be placed on the wound shield to control moisture,simplify wound monitoring and debridement and application ofmedications.

A wound shield according to the present disclosure may adhere to skinsurrounding a wound via adhesive applied to a surface of thewound-protecting frame to engage the skin. Medical grade, hypoallergenicadhesives are preferred, although any suitable adhesive may be used suchas rubber-based, acrylic, vinyl ether and suitable pressure-sensitiveadhesives. For their obvious advantages, adhesives that adhere to bodyhair less than their conventional counterparts are preferred. Adhesivesmay also be added to one or more surfaces of a wound-protecting framenot in contact with skin to engage any suitable dressing, cover, lid orany other suitable closure. Alternatively, no adhesive is used with thewound shield, and the wound shield is retained in place by the pressureapplied from the dressing wrapped around the wound.

A conformable wound shield frame may be provided in any suitabledispenser configuration. For example, the conformable frame may be woundaround a reel and placed in a dispenser that can be efficiently stored.When needed, the conformable frame may be fed out of the dispenser, andcut to desired lengths. Alternatively, the wound-protecting frame may besupplied in a sheet form and cut to the desired length and width.Moreover, the conformable frame may be prepackaged in several longstrips with various or equal widths that may be cut to desirablelengths.

In use, a conformable frame is placed around a wound, creating aboundary and providing a plane separate from the plane of the wound tosupport the dressing. The conformable frame may be used with anysuitable closure to engage the ends of the conformable frame andencircle a wound.

A wound shield according to the present disclosure may be fullydeformable to conform to specific contours of any wound located on anysurface of a body. It may be cut to a desirable length to enclose all orany portion of the perimeter of any wound, regardless of shape and size.In addition, the conformable frame may be made of inexpensive and yeteffective material.

Any suitable dressing may be used in conjunction with the conformableframe, and may range from inexpensive, commonly used cotton gauze tomore costly and sophisticated dressings, including for example, thoseconstructed from transparent and or multi-layered material withqualities such as exudate absorption, bacteria impermeability andcontrolled air and or moisture permeability. Health care professionalsmay mix and match various dressings without restriction to complexand/or costly non-contact dressings.

A wound shield according to the present disclosure has sufficientrigidity to prevent injurious contacts to the wound, including thosecaused by dressing adhering to the wound surface. The conformable frameprevents contact to wounds regardless of their size or location with anysuitable dressing.

A wound shield according to the present disclosure may be used for swiftand effective wound debridement using any suitable technique. Forexample, a wound shield may be used to create a controlled spaceadjacent a wound for biological debridement, use of maggots or othersuitable techniques. Alternatively, mechanical and or chemicaldebridement may also be effected within the controlled space. Surgicaldebridement may also be performed without removing the conformable framefrom around the wound. The wound shield minimizes wound and peri-wounddisturbance by avoiding repetitive dressing removals with the associatedwound surface disturbance.

A wound shield including a conformable frame to circumscribe a wound mayalso include a circulating system for circulating any suitable fluid tomaintain a desired environment. Any suitable dressing may be securedover the conformable frame providing separation between the wound andthe dressing. The wound frame may provide pressure relief around a woundor pressure sore to permit healing. A conformable frame may be composedof one or more layers of any suitable material and may include adhesiveon one or more surfaces to secure the frame to the wound site and or tosecure the dressing to the conformable frame.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a conformable frame according to thepresent disclosure.

FIG. 2 is a cross section of the conformable frame of FIG. 1 taken alongA-A.

FIG. 3 is an alternate cross section of the conformable frame of FIG. 1.

FIG. 4 is another alternate cross section of the conformable frame ofFIG. 1.

FIG. 5 is a still alternate cross section of the conformable frame ofFIG. 1.

FIG. 6 is a perspective view of an alternate conformable frame accordingto the present disclosure.

FIG. 7 is a top view of a conformable frame similar to FIG. 6illustrating alternative configurations.

FIG. 8 is a perspective view of a conformable frame surrounding a smallwound on the forearm.

FIG. 9 is a cross section of the conformable frame and dressing on thewound of FIG. 8.

FIG. 10 is a perspective view of a conformable frame surrounding a long,oddly shaped laceration on the forearm.

FIG. 11 is a perspective view of a conformable wound frame surroundingtwo proximately located wounds on the forearm.

FIG. 12 is a perspective view of an alternate configuration of aconformable wound frame surrounding two proximately located wounds onthe forearm.

FIG. 13 is a perspective view of a support or bridge member according tothe present disclosure.

FIG. 14 is a side view of an alternate support or bridge memberaccording to the present disclosure.

FIG. 15 is a perspective view of a conformable wound frame surroundingtwo proximately located wounds on the forearm.

FIGS. 16 and 16A are perspective views of connectors used in conjunctionwith a conformable member.

FIG. 17 is a perspective view of a dispenser according to the presentdisclosure.

FIGS. 17A and 17B are top views of conformable frame joints formed usingthe dispenser of FIG. 17.

FIG. 18 is a perspective view of an alternate deformable wound frameaccording to the present disclosure.

FIG. 19 is a cross section of the conformable frame of FIG. 18 takenalong C-C.

FIG. 19A is a cross section of the conformable frame of FIG. 18 takenalong C-C with an alternate scaffold.

FIG. 20 is an alternate cross section of the conformable frame of FIG.18.

FIG. 21 is another alternate cross section of the conformable frame ofFIG. 18.

FIG. 22 is yet another alternate cross section of the conformable frameof FIG. 18.

FIG. 23 is an alternate cross section of the conformable frame of FIG.18 with a wicking element.

FIG. 24 is another alternate cross section of the conformable frame ofFIG. 23.

FIG. 25 is a perspective view of an alternate conformable frameaccording to the present disclosure.

FIG. 26 is a cross section of an alternate conformable frame and lidconfiguration.

FIG. 27 is a cross section of another alternate conformable frame andlid configuration.

FIG. 28 is a cross section of a conformable frame with a vacuum lidconfiguration.

FIG. 29 illustrates a device for isolating a wound and providing heat tothe wound to encourage healing.

FIG. 30 illustrates the device of FIG. 29 modified to provide fluid flowover the wound to encourage healing.

FIG. 31 is another still alternate cross section of the conformableframe of FIG. 18.

FIG. 32 is yet another still alternate cross section of the conformableframe of FIG. 18.

FIG. 33 is a cross section of yet another alternate conformable frameconfiguration with an absorbent dressing.

FIG. 34 is a cross section of an alternate conformable frameconfiguration including exudate capture and storage.

FIG. 35 is a cross section of an alternate conformable frameconfiguration including exudate removal apertures and removal apparatus.

FIG. 36 is a perspective view of a conformable frame with an alternateconnector for joining the ends of the conformable frame.

FIG. 37 is a perspective view of an alternate deformable wound framespiral wrapped according to the present disclosure.

FIG. 38 is a cross section of the conformable frame of FIG. 37 takenalong D-D.

FIG. 39 is a side view of another alternate deformable wound frameaccording to the present disclosure.

FIG. 40 is a perspective view of an alternate deformable wound framewith exudate absorbent areas, spiral wrapped according to the presentdisclosure.

DETAILED DESCRIPTION OF THE INVENTIONS

Referring to FIG. 1 and FIG. 2, conformable frame 10 provides perimeterprotection for a wound and may conform to specific contours of the woundsite. Conformable frame 10 includes exterior side 14 facing away fromthe wound and interior side 16 facing the wound, superficial surface 12for engaging dressings and cutaneous surface 18 in contact with thepatient's skin, or any other dressing or apparatus in contact with thepatient's skin. Any suitable adhesive may be applied to cutaneoussurface 18 and or superficial surface 12 such as adhesive 28 and 22respectively. Adhesive layers 22 and 28 may also be covered by a stripor a film, such as film 24 and 26 respectively, that can be peeled offat the time of use. Adhesive 28 secures conformable frame 10 to skinsurrounding a wound, or in some applications, to a dressing or apparatusthat is in contact with the patient's skin. When applied to superficialsurface 12, adhesive layer 22 may engage a dressing or other suitablecover to conformable frame 10.

In use, conformable frame 10 includes a first end 13 and a second end15. When positioned around a wound, first end 13 and second end 15 maybe engaged to completely circumscribe the wound as shown in FIG. 8. Anadhesive or other suitable material may be applied to first end 13 andor second end 15 to secure the engagement of first end 13 and second end15. Conformable frame 10 may have any suitable cross-section as shown inFIG. 2 including height 30 and width 32. The size of a wound site to becircumscribed may require height 30 and width 32 to be available indifferent dimensions. Larger wounds may have a dressing sag andinadvertently contact the wound. First end 13 and or second end 15 maybe cut, preshaped or scored such that first end 13 and or second end 15are not perpendicular to the interior and exterior surfaces, or thesuperficial and cutaneous surfaces. The angle between the end surfaceand the side of the conformable frame may be selected to optimize thecurvature of the conformable frame, or to increase the mating surfaceareas of the ends.

Conformable frame 10 may be constructed from any suitable materialcapable of deformation in the X and or Y and or Z-axes. Silicone is oneexample of such material, as it is both rigid and deformable. Polymerssuch as polypropylene, polyethylene and polyurethane may also be used toform a deformable, and yet rigid wound protector. Depending on itsspecific use, additional features of a wound shield may includeimpermeability or controlled permeability to water, bacteria and air,and absorption of fluids exuding from the wound bed. A wound shieldaccording to the present disclosure may also include a selectablemoisture vapor transmission rate (MVTR). Polyurethane foam may be usedto form a wound-protecting frame for its ability to absorb exudates.

Referring now to FIGS. 3-5, alternative cross sections may be used. Anysuitable cross section may be used.

Referring now to FIG. 6, alternatively, a conformable frame such asconformable frame 34 may also include a plurality of grooves, cuts orslots such as grooves 36, positioned in either the wound or exteriorside such as exterior side 38. Grooves 36 may increase flexibility ofconformable frame 34 when constructed of material that may not havesufficient inherent flexibility to allow appropriate conformability.Grooves 36 may be cut or otherwise formed in conformable frame 34 usingany suitable technique.

Referring now to FIG. 7, alternate configurations of grooves 36 areillustrated for example. Any suitable geometry may be used for grooves36. Grooves or slots or cuts such as cuts 42 may also be combined inexterior side 38 as well as wound side 40 for increased flexibility.

Referring now to FIG. 8 and FIG. 9, conformable frame 46 may besuperficially applied to any injured surface of a patient such asforearm 44 using adhesive 58. Conformable frame 46 circumscribes wound48. First end 13 and second end 15 engage at plane 50. When dressing 52is used to promote healing of wound 48, conformable frame 46 preventsdressing 52 from contacting wound 48 by creating a separation 56 betweendressing 52 and wound plane or skin surface 54. Separation 56 iscontrolled by height 30 of the conformable frame.

As briefly described above, dressing 52 may be any suitable dressing.Dressing 52 may also include adhesive along its perimeter orlongitudinal and/or its transverse lengths, so to facilitate itsadherence to skin surrounding conformable frame 46. Alternatively,dressing 52 may be wrapped around the arm or other body parts on whichwound 48 is situated, or dressing 52 may be sized or cut to size toengage only conformable frame 46. Dressings such as dressing 52 may haveany suitable MVTR parameters.

Referring now to FIG. 10, dressing 60 may be used to secure conformableframe 66 around wound 64, which is a long, narrow, oddly shapedlaceration. Adhesive may be included around perimeter 62 of dressing 60.One or more dressing such as dressing 60 may be used. Dressing 60 may beapplied along the length, width, or in tandem with another dressing 60or other dressings to protect wound 64.

Referring now to FIG. 11, conformable frame 70 may be used to protectone or more proximately located wounds such as wounds 72 and 74 onforearm 76. Dressing 78 may be separated from scored dressing sheet 75which may have one or more dressings scored into sheet 75. Dressingssuch as dressing 52 or dressing 78 may be separated from sheet 75 alongscoring 52A or 78A respectively. Any size or number of dressings may bepre-scored into a dressing sheet such as sheet 75.

In an alternate configuration shown in FIG. 12 the connection of firstend 13 and second end 15 is transected by conformable frame 10. The useof a figure-8 shape provides dressing and pressure support betweenwounds 72 and 74. To prevent exudate from flowing away from wounds 72and 74 first end 13 and second end 15 may contact or otherwise engageside 14 and side 16 respectively.

A conformable frame according to the present disclosure may not alwayscompletely circumscribe a wound. For wounds positioned in awkward bodylocations, such as the elbow and knee or for any other reason, aconformable frame may be cut into two or more suitable lengths or frameelements. The frame elements may be positioned around the wound asdiscussed above. Such manipulation may allow positioning of a dressingwithout contacting the wound.

In certain circumstances health care professionals may recommend theairing of the wound, i.e., not covering the wound with any dressing. Assuch, a conformable frame according to the present disclosure may beused to simply protect the wound from physical contact with otherforeign objects, such as clothing or bed sheets. This configuration mayalso be suitable for treatment of any pressure or abrasion sores some ofwhich may be caused by long-term immobility. Conformable frame may beused to surround such sores and relieve the local pressure and permitthe sores to heal.

For patients allergic to medically approved adhesives, the conformableframe may be provided without adhesive or, alternatively, with adhesiveonly on surface 12. In such circumstances, conformable frame 10 must besecured to the wound site with sufficient and appropriate pressure toengage conformable frame 10 with the wound site.

For wound configurations such as illustrated in FIG. 11, particularlylarge wounds, structurally weak dressings or high pressure wound or soresites it may be necessary to provide additional support within theperimeter of a conformable frame to support the selected dressing orrelieve external pressure.

Referring now to FIG. 13, one or more bridge members such as bridgemember 80 may be used with the conformable frame of the presentdisclosure to provide additional wound protection. A bridge member maybe used with wounds having large surface area or with dressings havinglittle structural strength, or in situations where pressure may beapplied to the center of the wound area. Positioning of one or morebridge members such as bridge 82 on conformable frame 70, as depicted inFIG. 15, may prevent dressing 78 from sinking and touching wounds 72 or74.

A bridge member can have any suitable shape including straight or curvededges, ends or separations. A bridge may also be constructed frominexpensive medical grade rigid plastic polymers, metal or woodparticularly conditioned for medical use. Such material may bestructurally adapted to allow breakage or separation along segment linessuch as lines 86 and 88.

Medical grade adhesive may also be applied to second surface 90 whichwill come in contact with the conformable frame. A thin layer of film orstrip removable at time of use may cover the adhesive as discussed abovewith respect to the conformable frame. Alternatively, bridge member 80may have adhesive on both second side 90 and first side 92 to adhere notonly to the conformable frame, but also to the dressing.

Referring now to FIG. 14, alternate bridge member 84 includes aplurality of slots 94. Each slot or opening such as slot 94 may have anysuitable shape and dimension providing that width 96 is sized to permitengagement of a suitable conformable frame in the slot.

Referring now to FIG. 16, a connector such as connector 102 may be usedto join ends 104 and 106 of conformable frame 108 and provide completeclosure around a wound such as wound 100. Any suitable connector such asconnector 102 may be used in circumstances where it is desirable not toapply any adhesive to surfaces of conformable frame 108, or whererepetitive engagement and disengagement of first and second ends 104 and106 make adhesive impractical. Lack of adhesive provides the opportunityfor first end 104 and second end 106 to move away from one another andcreate an opening 110. As can be appreciated, exudate from wound 100, ifany, may diffuse away from wound 100 through opening 110 and onto otherbody surfaces.

Connector 102 may be used to close opening 110 by indirectly connectingfirst end 104 and second end 106. Connector member 102 may be hollow,and may be constructed from any suitable material, including those usedfor construction of conformable frames. Engagement receptacles 104A and106A may be slightly larger than the dimensions of first end 104 andsecond end 106 respectively. This permits conformable frame 108 to beinserted into connector member 102. Receptacles 104A and 106A shouldprovide secure engagement to first end 104 and second end 106respectively. Any other suitable configuration may also be used.Connectors such as connector 102 may also be used to connect two or moreconformable frames.

Alternative connector 102A is illustrated in FIG. 16A reinforcing theconnection between first end 104 and second end 106. Height h ofconnector 102A may be about one half height H of conformable frame 108.

Referring now to FIG. 17, conformable frames such as conformable frame10, conformable frame 34 and others may be stored and dispensed from anysuitable dispenser. For example, dispenser 120 may contain one or morecoils such as coil 122 wound around a reel or hub 124. Segment 126 maybe a portion of conformable frame from coil 122 that is withdrawnthrough outlet 128. Segment 126 may be pulled out from outlet 128 andcut to a desired length with scissors, or via one or more blades 130positioned adjacent outlet 128.

Alternatively, a dispenser may be sterilized, and or may have severaloutlets allowing it to contain several coils containing conformableframes having different dimensions and or characteristics. The number ofcoils or outlets contained in a dispenser are examples provided fordiscussion purposes only and should not be viewed as a limitation.

Referring now to FIG. 17A, conformable frame segment 126 is separatedfrom dispenser 120 forming first end 112 and second end 114. Duringseparation of segment 126 first end 112 and second end 114 were cut,scored or otherwise separated to form angle 116 with exterior side 118.Decreasing angle 116 increases the surface of the first and second endenabling greater engagement. A first end and second end may be cut tosimilar angled, complementary angles or different angles. Alternatively,first end 112 and second end 114 may be precut or otherwise prepared instandard lengths with assorted end profiles.

Referring now to FIG. 17B, first end 132 and second end 134 may be cutat a different angles 136 to simplify joining the first and second endsand form curves or shapes having small radii.

In use, a second conformable frame may be positioned on the superficialsurface of a first conformable frame. This configuration may be used insituations where a greater protective height around a wound ispreferable. A stacked assembly may include more than two conformableframes.

Referring now to FIG. 18, conformable frame 140 may have many differentcross sectional dimensions as well as constituent configurations.Conformable frames as discussed above may adopt any suitable geometry.For some applications it may be useful for a conformable frame to becomposed of two or more internal layers such as layers 150 and 152illustrated in FIG. 19. For example, layer 150 may be absorbent, or mayinclude any suitable antibiotic such as for example silver metal and orits salts. Layer 152 may be made from any suitable material.

In some situations it may be preferable to change one or more layersclosest to a wound when the layer or layers become saturated orotherwise unsuitable to remain close to the wound. Layer 150 may also beremovable to permit changing one or more layers. A scaffold or othersuitable apparatus such as scaffold 138 may be secured to exterior layer152. Internal layer 150 may be secured or otherwise engaged to either orboth layer 152 and scaffold 138.

Alternatively, internal layer 150 may be positioned using scaffold 138.Securing layer 150 to layer 152 and scaffold 138 using water solubleadhesive would simplify removal of layer 150 and may also serve toidentify a saturated layer as it separates from the structural layer andthe scaffold. If layer 150 needed to be changed, any dressing or lidapplied over conformable frame 140 may be disengaged. Layer 150 may beremoved and a replacement layer may be inserted using scaffold 138 as aguide and engagement mechanism.

Referring now to FIG. 19A, an alternate scaffold 139 may include lip 141to frictionally engage layer 150 without the use of adhesive or otherbonding agent. Scaffold 138 and or scaffold 139 may also include holesor other suitable openings such as holes 135 and 143 and openings 145 inshelf 133 and or lip 141 as illustrated in the associated close-upbottom views. Lip 141 may also permit usage and of any suitableabsorbent material in a non-contact position relative to the wound. Theabsorbent material may be frictionally engaged by lip 141 and supportedby scaffold 139.

Some materials may have directional characteristics, and when combinedin multiple layers may offer unique benefits. Many additionalcharacteristics may also be useful, for example, layer 156 of FIG. 20may be absorbent to absorb and retain exudate from the wound, and layer154 may be formed of a material providing dimensional stability orstructural integrity.

Similarly, referring to FIG. 22, layer 164 may be absorbent and layer166 may provide structural integrity and layer 166 may enclose layer 164to prevent exudates from wound side 144 transiting conformable frame 140and exiting through exterior side 146. Any suitable material may beselected for each layer. Layer 168 may be any suitable material.

Referring now to FIG. 21, layers 158, 160 and 162 may also provide oneor more diagnostic indicators such as for example, ph level,temperature, moisture level, O² levels or any other suitable parameter.The state of the parameter may be indicated by one or more color statesof one or more layers.

Referring now to FIG. 23, conformable frame 170 may include one or moreinternal layers such as layers 172, 174 and 176 and one or moreabsorbent appendages such as arm 178. Arm 178 and layer 176 may becomposed of any suitable material for absorbing exudates from wound 180.The physical geometry of arm 178 may vary for varying applications. Forexample, arm 184 shown in FIG. 24 provides vertical relief from wound180.

Alternatively as illustrated in FIG. 25, flexible absorbent appendagesmay also be secured to a conformable frame such as conformable frame192. Absorbent appendages 194 may be provided to absorb exudate fromwound 180. Any suitable material or combination of materials may be usedas appendages 194 such as for example natural fibers such as cotton orany suitable man-made fiber. Any other suitable configuration may alsobe employed such as enclosing one or more cotton balls or gauze withinthe space enclosed by a conformable frame and a covering dressing.

Referring now to FIG. 26, conformable frame 200 may also be used with acover or lid 202 to provide a controlled environment in enclosed space204 adjacent a wound site. Lid 202 may be removably engaged toconformable frame 200 using any suitable technique such as frictional oradhesive engagement. Lid 202 may be formed of any suitable material orcombination of materials such as a structural grid layer with one ormore laminate layers to obtain suitable performance and moisturetransmission/retention.

Alternatively, lid 202 may also include one or more absorptive elementssuch as cone 206 for removing moisture or exudate from wounds such aswound 210. Absorptive elements may have any suitable shape or dimensionand may be formed of any suitable material. For example, cone 206 may beformed of material that is selectively absorbent to remove exudate andunwanted fluids.

Enclosed space 204 may be further controlled as illustrated in FIG. 27.Conformable frame 212 may include one or more access ports such as inletport 214 and outlet port 216. Use of access ports permits irrigation,treatment, and or debridement of wound 210 without removing woundprotection shield 218. Fluid or other material may be introduced intoenclosed space 204 through inlet port 214. In the case of used fluid orexudate, removal may be accomplished using outlet port 216. Access portssuch as inlet port 214 and outlet port 216 may be reclosable to secureenclosed space 204. Alternatively, conformable frame 212 may be formedof material that permits a syringe to be inserted through theconformable frame for insertion of material or to remove material.Access ports may also be formed in the cover or lid 202.

Referring now to FIG. 28 enclosed vacuum space 211 may be created andmaintained by the use of a suitable cover or lid such as vacuum lid 205.A partial or complete vacuum may be created in space 211 by vacuumdevice 209 through adapter 207 or through a conformable frame such asconformable frame 212 using inlet port 214 or outlet port 216. Using aconformable frame and specifically adapted lid such as lid 205 maypermit a vacuum device such as vacuum device 209 to be located on lid205 without creating unsatisfactory pressure on or adjacent wound 210.Lid 205 may require an adapter such as adapter 207 or lid 205 may bespecifically formed to adapt to a vacuum device or connector to a vacuumdevice to create a full or partial vacuum within space 211.

FIG. 29 illustrates the wound isolation and warming device 220,including the conformable tube 221, inner absorbent ring or strip 222and breathable vapor barrier 223. The tube and absorbent strip areprovided with any suitable adhesive on the cutaneous surfaces of thetubing, the strip, or both, to secure the device to the skin of apatient. The conformable tubing is made of polyethylene or otherthermally conductive material, and is preferably conformable to theextent that it may either be bent and formed as necessary to conform tothe contours of a patient's body, though it may be supplied in straightlengths or in coils. The device also includes water supply and returnconduits 224, and a warm water source 225 comprising a water reservoir,heater 226 (or any other suitable heating means), pump 227, andappropriate thermostats, heating regulators and flow regulators.Pulsatile flow can be provided with roller pump or centrifugal pulsatileflow pump. The heater and thermostat are preferably operable to maintainwater temperature at a therapeutic temperature between about 36°-39° C.,but may be operated to maintain higher or lower temperatures asmedically indicated. The device is illustrated in place surroundingwound 100 on the skin of a patient.

The device may be modified as shown in FIG. 30, in which the tube 221 inthe vicinity of the wound is perforated, such that apertures 228distributed along the inner wall of tubing 221 and any interveningportion of conformable frame 222 direct water into the interior space229 (defined by the conformable frame) and onto the wound. Water iscollected through return tube 230 through suction ports 231 andappropriate suction pump 232 and collected in wastewater tank 233. Watermay be collected through a discrete segment of the tube formedintegrally with an interior wall or plug 234 provided to isolate thesupply and suction tubes. Alternatively, the suction tube may bebutt-joined with the supply tube. Used fluid may also be collected witha second, discrete suction tube, or through an additional lumen andports in the first tube.

Tube 221 may be made or formed in any cross section shape including butnot limited to cylindrical, rectangular, trapaziodal or any othersuitable shape. A suitable shape of tube 221 may be selected to controlthe flow of thermal energy around the wound, generally to increase thetemperature of the wound site, however cooling may also be provided.Tube 221 may also include one or more insulating layers to control thethermal energy and prevent unwanted losses. Adhesive may also be used asnecessary on tube or its adjacent surfaces to secure tube 221 in use.

In use, the devices of FIGS. 29 and 30 are applied to a patient so thatthe conformable tubing substantially circumscribes a wound, and fixed tothe skin of the patient with adhesives on the cutaneous surfaces of theconformable tubing and absorbent ring (or secured with bandages,wherever adhesives are inadequate or inappropriate). The pump and heaterare operated to maintain warm fluid flow through the tube, to maintain awarm environment proximate the wound. In the closed system of FIG. 29,the fluid is returned to reservoir, reheated and re-circulated throughthe system. When using the device of FIG. 30, the suction pump isoperated to draw fluid from the wound environment and deliver that fluidto the wastewater tank. Therapeutic agents such as antibiotics may beadded to the warm water source when medically indicated.

Referring now to FIG. 31, absorbent layer 164 may be reoriented to beout of contact with the patients skin. Absorbent layer 164 may beconfigured to absorb and store exudate from a wound. Relief such asrelief 240 isolates the absorbed exudate away from the patients skin.Relief 240 may be selected to be any suitable dimension.

Dynamic exudate management and removal may be provided by layer 242 ofFIG. 32. The material of layer 242 is selected to flex when new and toextend over relief 244 and contact the surface of a wound to engageexudate. Upon absorbing exudate, layer 242 will contract to draw exudateacross relief 244 to continue wicking exudate from the wound withabsorbent layer 242 out of contact with the wound or the patients skin.

Referring to FIG. 33, exudate 246 may be conducted from wound 210 andenclosed space 258 with alternate conformable frame 248. The material oflayer 250 may be selected to perform as a conduit by drawing exudate 246from wound 210 and transferring exudate 246 to one or more storagelayers of dressing 252 such as layer 254. Layer 250 will not retainexudate 246. Absorbent layer 254 may be any suitable material and mayalso be expandable. Area 256 of dressing 252 may permit viewing of wound210 and may have a selected permeability to enhance control of enclosedspace 258.

Wound 260 of FIG. 34 may produce exudate 263. An alternate conformableframe 262 may conduct exudate away from wound 260. Membrane 264 maysurround conformable frame 262 or may otherwise be included as a layerof conformable frame 262. Membrane 264 may allow exudate to pass in onlyone direction, away from the wound. Once exudate 263 has passed membrane264 it may be absorbed or otherwise conducted along drain 261 away fromthe wound. Drain 261 may include an access port 266 which mayaccommodate continuous or intermittent connection for withdrawal ordrainage of exudate from drain 261 into reservoir 265. Reservoir 265 maybe adjacent to wound 260 or may be remotely located by interconnectingreservoir 265 to drain 261 with a tube or other suitable element.Alternatively, reservoir 265 may be used to introduce water or othersuitable solvent or cleanser into drain 261 to expedite removal ofexudate 263.

Use of access ports permits exudate management with irrigation,treatment, and or debridement of a wound such as wound 270 withoutremoving wound protection shield 272. Fluid and or other material may beintroduced, and exudate, fluid and or other material may be removed fromenclosed space 276 through port 274. Access ports such as port 274 mayadopt any suitable geometry for engaging various tubes, such as tube271, syringes, and devices such as reservoir 273. Ports may bereclosable using any suitable technique to secure enclosed space 276.

Adapters such as adapter 275 may engage port 274 to permit leakproofaccess to enclosed space 276. As adapter 275 enters port 274 the port isopened, and as adapter 275 is withdrawn port 274 closes and withdrawalof an adapter cleanses port 274.

Alternatively, one or more access ports such as access port 282 may alsobe included in connectors such as connector 280 of FIG. 36. Connector280 may be used to engage ends 284 a and 284B of conformable frame 284.

Referring now to FIG. 37 conformable frame 306 may be wrapped one ormore times around a wound such as wound 300 forming a spiral frame. Thisapplication permits fast application of conformable frame 306. First end302 is applied to a location adjacent the wound and conformable frame306 is wound around the wound until the conformable frame hascircumscribed the wound and the remainder of the conformable frame isapplied in a spiral with outer edge 303 of the applied frame in contactwith inner edge 301 of the adjacent wrap forming joint 308. Thisapplication increases the surface area of conformable frame in contactwith the patient to distribute pressure applied to the wound area to agreater area of the patient's body, and at a greater distance from theactual wound.

Referring now to FIG. 38, a conformable frame spiral may be formed usinga frame having a constant height 312. Alternatively, height 312 may varyfrom first end 302 to second end 304 resulting in a cross-section asshown. Inner wrap 311 has the lowest height 312 and subsequent wrapssuch as wraps 313 and 315 have increasing heights. The height variationsmay be distinct such as steps, or it may be gradual and continuous. Theheight variations distribute pressure that might otherwise impact thewound, to surrounding tissue removed from the wound. As pressureincreases compressing outer wraps of conformable frame 310, the innerwraps begin to provide support increasing pressure resistance.Conformable frame 310 may be formed of one or more layers 314 and or 316as discussed above.

Conformable frame 320 of FIG. 39 illustrates a continuously increasingheight from first end 322 to second end 324. Characteristics ofconformable frame 320 may change gradually and continuously from firstend 322 to second end 324 or there may be one or more zones such aszones 328 a, 328 b, 328 c and or 328 d. Each zone may have differentcompression resistance, absorbance or any other suitablecharacteristics.

Conformable frame 408 of FIG. 40 may be spiral wrapped around wound 400as discussed above. Conformable frame 408 may include one or more areasof absorbent material such as areas 401. Non-absorbent sections 406 mayseparate absorbent areas 401. This configuration prevents absorbedexudate and or other fluids from leaking from conformable frame 408. Ifconformable frame 408 is used with an absorbent cover, bandage or othertop, absorbent areas 401 in outer wraps may operate as additionalexudate storage without direct access to wound 400.

Thus, while the preferred embodiments of the devices and methods havebeen described in reference to the environment in which they weredeveloped, they are merely illustrative of the principles of theinventions. Other embodiments and configurations may be devised withoutdeparting from the spirit of the inventions and the scope of theappended claims.

1. A wound shield comprising: a conformable frame circumscribing thewound in a spiral forming two or more wraps; a cover engaging theconformable frame forming an enclosed wound space within the conformableframe spiral.
 2. The wound shield of claim 1 wherein the conformableframe further comprises one or more absorbent layers with the absorbentlayer adjacent the wound.
 3. The wound shield of claim 1 wherein eachwrap of the two or more wraps of the conformable frame have differentheights, with the lowest height adjacent the wound and increasing heightaway from the wound.
 4. A method of protecting one or more woundscomprising: applying a first end of a conformable frame proximate awound to be protected; circumscribing the wound to be protected with theconformable frame; wrapping the conformable frame around thecircumscribed wound in a spiral; and securing a cover to the spiralwrapped conformable frame enclosing a space adjacent the wound to beprotected.
 5. The wound shield of claim 1 wherein the conformable framehas two or more zones and a first zone is adjacent the wound, the firstzone comprising two or more layers with the layer adjacent the woundbeing absorbent.
 6. The wound shield of claim 3 wherein the conformableframe has two or more zones and a first zone comprises the first wrapand is adjacent the wound, the first zone comprising two or more layerswith the layer adjacent the wound being absorbent.
 7. The wound shieldof claim 1: wherein the conformable frame has two or more zones and afirst zone is adjacent the wound, the first zone comprising two or morelayers with the layer adjacent the wound being absorbent; and wherein aportion of the cover is transparent and the non-transparent portion isabsorbent.